BMS and Pfizer give apixaban update

Bristol-Myers Squibb and Pfizer have published an update on the clinical development programme for apixaban.

The companies will present new phase II clinical data for the compound in acute coronary syndrome patients at the upcoming meeting of the European Society of Cardiology next month.

An early evaluation of a phase III study of the compound for the prevention of venous thromboembolism in total knee replacement patients has shown its primary endpoint has not been met, the company said.

Consequently the regulatory filing for this indication will not be submitted during 2009.

Other clinical programmes for the compound will continue as planned.

Jack Lawrence, vice president of research and development at BMS, said: “BMS and Pfizer remain enthusiastic and committed to the clinical development program for apixaban.”

He added the companies anticipate the full results of the Appraise-1 study being presented next month will offer key insight into the potential use of the drug for the secondary prevention of cardiovascular events in acute coronary syndrome patients.

In June 2008, BMS and Pfizer announced the initiation of the Amplify trial as part of the phase III Expanse study of apixaban.

The trial will assess the effects of the drug on patients with blood clots in their lungs or leg veins.